Device with co-extruded body and flexible inner bladder and related apparatus and method

ABSTRACT

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 14/930,896, filed Nov. 3, 2015, now U.S. Pat. No. 9,663,274issued May 30, 2017, which is a continuation of U.S. patent applicationSer. No. 13/847,277, filed Mar. 19, 2013, now U.S. Pat. No. 9,211,983issued Dec. 15, 2015, which is a continuation of U.S. patent applicationSer. No. 12/577,126, filed Oct. 9, 2009, now U.S. Pat. No. 8,397,950issued Mar. 19, 2013, which claims the benefit under 35 U.S.C. § 119(e)of U.S. Provisional Patent Application No. 61/104,613, filed Oct. 10,2008, entitled “Device with Co-Extruded Body and Flexible Inner Bladderand Related Apparatus and Method,” all of which are hereby incorporatedby reference in their entirety as part of the present disclosure.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to devices, such as containers, definingvariable-volume storage chambers and methods of making such devices, andmore particularly, to such devices with co-extruded outer bodies andinner bladders and to related methods.

Background Information

One of the drawbacks of current devices for storing products, such asfood or medicinal products, is that the multiple parts of the devicesmust be manufactured separately, such as by molding, and then assembledtogether. This can be particularly time consuming and expensive when thedevices are used for storing sterile food products, medicinal products,or other products requiring that the products be sterile filled and/ormaintained sealed with respect to ambient atmosphere during storageand/or use of the device. For example, in devices including flexiblebladders defining variable-volume storage chambers and relatively rigidouter bodies or housings, the bladders are formed separately from theouter bodies, and the bladders are filled, or otherwise assembled to theouter bodies and then filled. These multiple assembly steps can be timeconsuming and expensive and can subject the various parts tocontamination.

Accordingly, it is an object of the present invention to overcome one ormore of the above-described drawbacks and/or disadvantages of the priorart.

SUMMARY OF THE INVENTION

In accordance with a first aspect, the present invention is directed toa device comprising a first portion including a first polymer, and asecond portion that is relatively flexible in comparison to the firstportion and includes a second polymer that is substantially not bondableto the first polymer. A chamber of the device is hermetically sealablewith respect to ambient atmosphere and is defined by (i) an interior ofthe second portion, and/or (ii) a space formed between the first andsecond portions. A third portion of the device includes a third polymerthat is bondable to the first and second polymers and fixedly securesthe first and second portions to each other.

In some embodiments of the present invention, the first polymer includesfirst and second monomers, the second polymer includes third and fourthmonomers that are different than the first and second monomers andsubstantially not bondable thereto, and the third polymer includes fifthand sixth monomers. The fifth monomer is at least substantially similarand bondable to the first and/or second monomers for bonding the thirdpolymer to the first polymer, and the sixth monomer is at leastsubstantially similar and bondable to the third and/or fourth monomersfor bonding the third polymer to the second polymer. In some suchembodiments, the fifth monomer is the same as or substantially the sameas the first and/or second monomers, and the sixth monomer is the sameas or substantially the same as the third and/or fourth monomers.

In some embodiments of the present invention, the first, second andthird portions are co-extruded. In some such embodiments, the first,second and third portions are co-extrusion blow-molded. In someembodiments of the present invention, the first portion defines arelatively rigid outer body, the second portion defines a relativelyflexible inner bladder, and the third portion fixedly secures the outerbody and/or the inner bladder to the other.

In some embodiments of the present invention, the chamber is avariable-volume storage chamber, and the device further comprises aone-way valve fixedly secured to the first, second and/or third portionsof the device and in fluid communication with the chamber. The one-wayvalve defines a normally closed position that hermetically seals thechamber with respect to the ambient atmosphere, and an open positionthat allows substance to flow out of the chamber and device through theone-way valve. In some such embodiments, the one-way valve substantiallyprevents the ingress of bacteria and other contaminants into the chamberin both the closed and open positions.

In some embodiments of the present invention, the one-way valve includesa flexible valve member that is movable from the closed to the openposition in response to substance at an inlet to the one-way valveexceeding a valve opening pressure. In some such embodiments, theflexible valve member defines a normally closed axially-extending valveopening. Preferably, the one-way valve further includes a relativelyrigid valve seat that engages the flexible valve member in the normallyclosed position and defines the normally closed axially-extending valveopening therebetween.

In some embodiments of the present invention, the one-way valve includesa valve member formed of an elastic material and including anaxially-extending valve portion forming a normally closed,axially-extending valve opening. The valve portion is movable radiallybetween a normally closed position, and an open position with at least asegment of the valve portion spaced radially away from the closedposition to connect the valve opening in fluid communication with thevariable-volume chamber, and thereby allow the passage of fluid from thevariable-volume chamber through the valve opening.

In some embodiments of the present invention, the device furthercomprises a pump coupled between the variable-volume chamber and theone-way valve for pumping substance from the chamber through the one-wayvalve. In some such embodiments, the pump is configured to pump discreteportions of substance from the chamber through the one-way valve. Duringpumping, the one-way valve and chamber maintain any remaining substancein the chamber in an aseptic condition and sealed with respect toambient atmosphere.

In some embodiments of the present invention, the pump includes acompression chamber, a compressive surface receivable within thecompression chamber, and a manually-engageable actuator coupled to thecompression chamber and/or compressive surface. The compressive surfaceand/or compression chamber is movable relative to the other by themanually-engageable actuator between (i) a rest position, and (ii) atleast one actuated position for pressurizing fluid within thecompression chamber and, in turn, dispensing fluid through the one-wayvalve. In some such embodiments, the compressive surface and/orcompression chamber is movable relative to the other by themanually-engageable actuator between (i) a first position with thecompression chamber coupled in fluid communication with thevariable-volume chamber for receiving fluid from the variable-volumechamber into the compression chamber, and (ii) a second position withthe compressive surface received within the compression chamber, and thecompression chamber substantially sealed with respect to thevariable-volume chamber to pressurize fluid within the compressionchamber and, in turn, dispense pressurized fluid through the one-wayvalve. In some such embodiments, a flexible member defines on one sidethereof the manually-engageable actuator, and defines on another sidethereof the compressive surface. In some such embodiments, the flexiblemember is substantially dome shaped, and the compression chamber isdefined by a recess opposing the substantially dome-shaped flexiblemember.

In some embodiments of the present invention, the pump is co-molded withthe one-way valve. In some such embodiments, the pump and one-way valveform a pump and valve assembly including a base defining a valve seat, arelatively flexible manually-engageable actuator for pumping substancethrough the one-way valve, and a relatively flexible valve memberengaging the valve seat and forming a normally closed valve openingtherebetween. In some such embodiments, the pump and valve assemblyfurther comprises (i) a penetrable and laser resealable portion, and/or(ii) a one-way filling valve for filling the variable-volume chamber.

In some embodiments of the present invention, the penetrable and laserresealable portion and/or the one-way filling valve is co-molded withthe pump and valve assembly. In some such embodiments, the pump andvalve assembly includes a support surface formed integral with the baseand movable relative thereto. The manually-engageable actuator and valvemember are co-molded to the support surface. The support surface ismovable into engagement with the base to fixedly secure the supportsurface to the base and form a fluid-tight seal, and to place the valvemember in engagement with the valve seat forming the normally closedvalve opening. Preferably, a flexible gasket is formed on the base andengageable between the base and the body to form a fluid-tight seal. Insome such embodiments, the gasket is co-molded with themanually-engageable actuator and valve member. In some embodiments ofthe present invention, the pump and valve assembly further includes anintegral or living hinge extending between the support and base forallowing movement of at least one relative to the other.

In some embodiments of the present invention, at least a portion of thepump, the one-way valve, and/or a surface defining the variable-volumechamber is penetrable by an injection member for filling thevariable-volume chamber through the injection member with a fluid to bestored therein, and the resulting penetration aperture is thermallyresealable such as by applying laser energy thereto.

In accordance with another aspect, the present invention is directed toa device comprising first means for forming an outer surface of thedevice and including a first polymer. Second means of the deviceincludes a second polymer that is substantially not bondable to thefirst polymer for forming a relatively flexible inner surface of thedevice in comparison to the first means, and a chamber that ishermetically sealable with respect to ambient atmosphere and defined by(i) an interior of the second means, and/or (ii) a space formed betweenthe first and second means. Third means of the device includes a thirdpolymer that is bondable to the first and second polymers for fixedlysecuring the first and second means to each other. In some embodimentsof the present invention, the first means is a relatively rigid outerbody, the second means is a relatively flexible inner bladder, and thethird means is a portion of the device that is bonded to and fixedlysecures the body and/or bladder to the other. Preferably, the body,bladder and portion bonded thereto are co-extrusion blow molded.

In accordance with another aspect, the present invention is directed toa method comprising the following steps:

(i) extruding a first portion of a device including a first polymer;

(ii) co-extruding with the first portion a second portion of the devicethat is relatively flexible in comparison to the first portion, and thatincludes a second polymer that is substantially not bondable to thefirst polymer;

(iii) co-extruding a third portion of the device including a thirdpolymer that is bondable to the first and second polymers; and

(iv) bonding the third portion to the first and second portions tofixedly secure the first and second portions to the third portion, andforming a chamber that is hermetically sealable with respect to ambientatmosphere defined by (i) an interior of the second portion, and/or (ii)a space formed between the first and second portions.

Some embodiments of the present invention further comprise co-extrusionblow molding the first, second and third portions. Some such embodimentsfurther comprise substantially simultaneously co-extruding the first andsecond polymers, sequentially co-extruding the third polymer and, inturn, bonding the third polymer to the first and second polymers tofixedly secure the first, second and third portions to each other. Somesuch embodiments further comprise extruding a first parison of the firstpolymer, co-extruding a second parison of the second polymer within thefirst parison, sequentially co-extruding a third parison of the thirdpolymer, and bonding the third polymer to each of the first and secondpolymers.

Some embodiments of the present invention further comprise co-molding apump and one-way dispensing valve assembly, and fixedly securing thepump and one-way dispensing valve assembly to the first, second and/orthird portions. The one-way dispensing valve is in fluid communicationwith the variable-volume chamber, and the variable-volume chamber ishermetically sealed with respect to ambient atmosphere.

In some embodiments of the present invention, the co-molding stepincludes co-molding as part of the pump and valve assembly (i) apenetrable and thermally resealable portion, and/or (ii) a one-wayfilling valve. In some such embodiments, the co-molding step includesco-molding as part of the pump and valve assembly a penetrable andthermally resealable portion. In these embodiments, the aseptic fillingstep includes penetrating the penetrable and thermally resealableportion with an injection member placed in fluid communication with thevariable-volume chamber, filling the variable-volume chamber through theinjection member, withdrawing the injection member, and thermallyresealing, such as by applying laser energy to, a resulting penetrationaperture formed in the penetrable and thermally resealable portion.

In some embodiments of the present invention, the co-molding stepincludes co-molding as part of the pump and valve assembly a one-wayfilling valve in fluid communication with the variable-volume chamber.In these embodiments, the aseptic filling step includes placing afilling member in fluid communication with an inlet of the one-wayfilling valve; filling the sterile fluid through the filling member andone-way filling valve and into the variable-volume chamber; removing thefilling member from the one-way filling valve; and sealing thevariable-volume chamber with respect to ambient atmosphere with theone-way filling valve.

Some embodiments of the present invention further comprise forming asealed, empty, sterile variable-volume chamber. In some suchembodiments, the step of forming a sterile variable-volume chamberincludes subjecting the sealed, empty, variable-volume chamber toradiation. In some such embodiments, the radiation is gamma radiation.Some embodiments of the present invention comprise the steps ofco-molding the pump and valve assembly or other device closure;co-extruding the first, second and third portions of the device, such asthe relatively rigid outer body, flexible inner bladder, and neck; uponmolding the two parts, promptly assembling the closure to the neck in anaseptic environment, such as under an overpressure of sterile air, andthereby forming a sealed, empty, sterile variable-volume chamber. Someembodiments of the present invention further comprise asepticallyfilling the sealed, empty, variable-volume chamber with a sterile fluid.

One advantage of the device and method of the present invention is thatthe first portion, such as the outer body of the container or otherdevice, and the second portion, such as the inner bladder of thecontainer or other device, can be molded at the same time as one part.Yet another advantage of some currently preferred embodiments of thepresent invention is that the pump and valve assembly, and/or the pump,penetrable and thermally resealable stopper or filling valve, anddispensing valve assembly, can be co-molded in one part, and attached tothe outer body and flexible inner bladder, thus forming such device inapproximately two parts.

Other advantages of the present invention and/or of the preferredembodiments thereof will become more readily apparent in view of thefollowing detailed description of the currently preferred embodimentsand accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B and 1C are somewhat schematic, partial cross-sectionalviews of a device embodying the present invention, including arelatively rigid outer body, a flexible inner bladder defining avariable-volume storage chamber, and a neck, that are co-extrusion blowmolded as one part, and showing in FIG. 1A the filled inner bladder, inFIG. 1B the inner bladder with a portion of the stored fluid dispensedtherefrom, and in FIG. 1C the empty bladder after substantially all ofthe fluid is dispensed therefrom;

FIG. 2 is a somewhat schematic, cross-sectional view of the device ofFIGS. 1A, 1B, and 1C including a pump and dispensing valve assemblyfixedly secured to the neck and forming a fluid-tight seal therebetweenfor pumping discrete portions of fluid through the one-way valve, andmaintaining the fluid remaining in the variable-volume storage chambersealed with respect to the ambient atmosphere;

FIG. 3 is a top plan view of an open pump and valve assembly in anembodiment of an invention prior to assembly to the neck including aco-molded pump, dispensing valve, and needle penetrable and laserresealable stopper for needle filling the variable-volume storagechamber, and laser resealing the resulting needle aperture to seal thevariable-volume storage chamber with respect to the ambient atmosphere;

FIG. 4 is a somewhat schematic, elevational view of an assembled deviceusing the pump and valve assembly of FIG. 3 in an embodiment of theinvention; and

FIG. 5 is a top view of the assembled device of FIG. 4.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In FIGS. 1A, 1B and 1C, a device embodying the present invention isindicated generally by the reference numeral 10. The device 10 includesa first portion or relatively rigid outer body 12 including a firstpolymer, and a second portion or relatively flexible inner bladder 14that is relatively flexible in comparison to the outer body, andincludes a second polymer that is substantially not bondable to thefirst polymer. A chamber 16 of the device is hermetically sealable withrespect to ambient atmosphere and is defined by an interior of the innerbladder 14. Alternatively, if desired, the chamber 16 may be defined bya space formed between the first and second portions 12 and 14,respectively, such as a space 26 formed between the flexible innerbladder 14 and outer body 12. A third portion 18 of the device 10defines a neck of the container that fixedly secures the outer body 12and flexible inner bladder 14 to each other. The neck 18 includes athird polymer that is bondable to the first and second polymers tofixedly secure the outer body 12 and flexible inner bladder 14 to eachother. As described further below, in the illustrated embodiments of theinvention, the first, second and third portions 12, 14 and 18,respectively, are co-extruded, and preferably are co-extrusionblow-molded.

In the illustrated embodiments, the first polymer forming the outer body12 includes first and second monomers, the second polymer forming theflexible inner bladder 14 includes third and fourth monomers that aredifferent than the first and second monomers and substantially notbondable thereto, and the third polymer forming the neck 18 includesfifth and sixth monomers. The fifth monomer is at least substantiallysimilar and bondable to the first and/or second monomers for bonding thethird polymer/neck 18 to the first polymer/outer body 12, and the sixthmonomer is at least substantially similar and bondable to the thirdand/or fourth monomers for bonding the third polymer/neck 18 to thesecond polymer/flexible inner bladder 14. In the illustrated embodiment,the fifth monomer is the same as or substantially the same as the firstand/or second monomers, and the sixth monomer is the same as orsubstantially the same as the third and/or fourth monomers. As may berecognized by those of ordinary skill in the pertinent art based on theteachings herein, the first, second and third polymers, and the monomersforming each of the polymers, may take the form of any of numerousdifferent polymers and/or monomers that are currently known, or thatlater become known, for performing the functions of the polymers andmonomers as described herein. Further, the devices may take any ofnumerous different configurations, and the components of the devices maytake any of numerous different physical and/or chemical characteristics,that are currently known, or that later become known. In the exemplaryillustrated embodiment, the outer body 12 may be relatively rigid incomparison to the flexible inner bladder 14, but nevertheless may bemanually squeezable to pressurize the inner bladder 14 and, in turn,pressure the fluid or other substance within the variable-volume chamberto dispense fluid or other substance therefrom.

As shown in FIGS. 1A-1C, the outer body 12 defines a relatively rigidbase 20 that is co-molded with, and fixedly engages a base portion 22 ofthe flexible inner bladder 14 to fixedly secure the base of the bladderto the base of the outer body, and to form a fluid tight seal at thebase of the inner bladder. The base 20 of the outer body 12 furtherdefines a fluid flow aperture 24 that extends through the base and is influid communication with the second variable-volume chamber 26 locatedbetween the flexible inner bladder 14 and relatively rigid outer body12. The fluid flow aperture 24 allows fluid, such as air, to flow fromthe ambient atmosphere into the second variable-volume chamber 26 toaccommodate changes in volume in the first variable-volume chamber 16,for example, after dispensing fluid therefrom. In the illustratedembodiment, the fluid flow aperture 24 is in the nature of a pin hole;however, as may be recognized by those of ordinary skill in thepertinent art based on the teachings herein, the fluid-flow aperture 24may take any of numerous different configurations that are currentlyknown, or that later become known. For example, if desired, thefluid-flow aperture 24 may include within it or otherwise be defined asa one-way valve, such as an air check valve, that allows air to flowinto the second variable-volume chamber 26 as fluid is dispensed fromthe first variable-volume chamber 16. In one such embodiment, the checkvalve allows the air in the second variable-volume chamber 26 to becomepressurized upon manually squeezing the outer body 12 to, in turn,pressurize the fluid or other substance in the first variable-volumechamber 16 and, for example, facilitate dispensing such fluid or othersubstance.

Also in the illustrated embodiments, the chamber 16 is a variable-volumestorage chamber, and as shown in FIGS. 2 through 4, the device 10further comprises a one-way dispensing valve 28 fixedly secured to theneck 18 and in fluid communication with the first variable-volumechamber 16. The one-way valve 28 defines a normally closed position thathermetically seals the first variable-volume chamber 16 with respect tothe ambient atmosphere, and an open position that allows substance toflow out of the chamber 16 and device through the one-way valve 28.Preferably, such as in the application of the device for food products,such as sterile foods, or medicinal products, the one-way valve 28substantially prevents the ingress of bacteria and other contaminantsinto the chamber 16 in both the closed and open positions (i.e.,throughout storage and the period of dispensing of product from thedevice).

As shown in FIG. 3, the one-way valve 28 includes a flexible valvemember 30 that is movable from the closed to the open position inresponse to substance at an inlet 32 to the one-way valve exceeding avalve opening pressure. The one-way valve 28 includes a relatively rigidvalve seat 34 that engages the flexible valve member 30 in the normallyclosed position, and defines a normally closed axially-extending valveopening 36 therebetween. The valve member 30 is formed of an elasticmaterial and includes an axially-extending valve portion 38 forming thenormally closed, axially-extending valve opening 36. The valve portion38 is movable radially between a normally closed position, and an openposition with at least a segment of the valve portion 38 spaced radiallyaway from the closed position to connect the valve opening 36 in fluidcommunication with the variable-volume chamber 16, and thereby allow thepassage of fluid from the variable-volume chamber 16 through the valveopening 36.

The device 10 further comprises a pump 40 coupled between thevariable-volume chamber 16 and the one-way valve 28 for pumpingsubstance from the chamber 16 through the one-way valve 28. The pump 40is configured to pump discrete portions of substance from the chamber 16through the one-way valve 28. During pumping, the one-way valve 28 andchamber 16 maintain any remaining substance in the chamber in an asepticcondition and sealed with respect to ambient atmosphere.

As shown in FIGS. 2 and 3, the pump 40 includes a compression chamber42, a compressive surface 44 receivable within the compression chamber42, and a manually-engageable actuator 46 overlying the compressivesurface 44 in fluid communication with the compression chamber. Thecompressive surface 44 and/or compression chamber 42 is movable relativeto the other by the manually-engageable actuator 46 between (i) a restposition, as shown typically in FIG. 4, and (ii) at least one actuatedposition for pressurizing fluid within the compression chamber 42 and,in turn, dispensing fluid through the one-way valve 28. In theillustrated embodiment, the compressive surface 44 and/or compressionchamber 42 is movable relative to the other by the manually-engageableactuator 46 between (i) a first position, as shown typically in FIG. 4,with the compression chamber 42 coupled in fluid communication with thevariable-volume chamber 16 for receiving fluid from the variable-volumechamber into the compression chamber, and (ii) a second position (notshown) with the compressive surface 44 received within the compressionchamber 42 to pressurize fluid within the compression chamber and, inturn, dispense pressurized fluid through the one-way valve 28. In theillustrated embodiment, a flexible, substantially dome-shaped memberdefines on one side thereof the manually-engageable actuator 46, anddefines on opposite side thereof the compressive surface 44, and thecompression chamber 42 is defined by a recess opposing the substantiallydome-shaped flexible member.

Also in the illustrated embodiments, the pump 40 is co-molded with theone-way valve 28. As shown in FIG. 3, the pump and one-way valve form apump and valve assembly 48 including a base 50 defining the valve seat34, and an inlet opening 52 in fluid communication between thecompression chamber 42 of the pump and the variable-volume chamber 16.The inlet opening 52 may have an inlet 64 in fluid communication withthe variable volume storage chamber. The pump and valve assembly 48further comprises a support 54 that is co-molded with the base 50, and aflexible hinge 56 (or “living hinge”) extending between the support 54and base 50 that allows the support 54 to be folded over the base andfixedly secured thereto to assemble the pump and valve assembly. Thesupport may further have a seal 66 in register with the inlet 64. Thesupport 54 includes molded thereon the relatively flexiblemanually-engageable actuator 46 and underlying compressive surface 44for pumping substance through the one-way valve, and the relativelyflexible valve member 30 that engages the valve seat 34 when the support54 is folded over and assembled to the base 50 forming an interferencefit therebetween and defining the normally closed valve opening 36.

The pump and valve assembly 48 further comprises a penetrable andthermally resealable portion 58 that is co-molded to the support 54 andoverlies an aperture 60 in the base 50 when attached thereto. Thepenetrable and thermally resealable portion 58 allows fillingtherethrough of the variable-volume chamber 16 with a needle or likeinjection member, and thermal resealing of the resulting penetrationaperture, such as by applying laser radiation thereto.

As show in FIGS. 3, 4 and 5, the support 54 is movable into engagementwith the base 50 to fixedly secure the support to the base and form afluid-tight seal therebetween (i.e., the base of the dome-shapedactuator engages the surface defining the corresponding inlet aperture52, and the needle penetrable and thermally resealable portion 58engages the surface defining the corresponding aperture 60 to formfluid-tight seals therebetween), and to place the valve member 30 inengagement with the valve seat 34 and form the normally closed valveopening 36 therebetween. Further, seal 66 is placed into register withthe inlet 64 so as to seal the compression chamber 42 with respect tothe variable volume storage chamber 16 during pressurization of thefluid in the compression chamber 42. The seal 66 is of a material, aswould be known to those in the art, so as to be sufficientlydisplaceable from the inlet 64 so fluid may be received from thevariable-volume chamber 16 into the compression chamber 42. As shown inFIG. 3, a flexible gasket 62 is formed on the base 50 and is engageablebetween the base and the neck 18 to form a fluid-tight sealtherebetween. In the illustrated embodiment, the gasket 62 is co-moldedwith the manually-engageable actuator 46, valve member 30 and needlepenetrable and thermally resealable portion 58. However, as may berecognized by those of ordinary skill in the pertinent art based on theteachings herein, these components can be molded separately and thenassembled, or otherwise formed in any of numerous different ways thatare currently known, or that later become known.

The currently preferred embodiment of the device 10 is manufactured inaccordance with the following steps:

(i) extruding the first portion or body 12 that includes the firstpolymer;

(ii) co-extruding with the first portion or body 12 the second portionor flexible inner bladder 14 that includes the second polymer that issubstantially not bondable to the first polymer;

(iii) co-extruding the third portion or neck 18 that includes the thirdpolymer that is bondable to the first and second polymers; and

(iv) bonding the third portion or neck 18 to the first and secondportions or body and flexible inner bladder 12 and 14, respectively, tofixedly secure the body and inner bladder to the neck.

In the illustrated embodiment, the body 12, bladder 14 and neck 18 areco-extrusion blow molded. Preferably, the method of manufacture involvessubstantially simultaneously co-extruding the first and second polymers,sequentially co-extruding the third polymer and, in turn, bonding thethird polymer (or neck 18) to the first and second polymers (or body 12and inner bladder 14) to fixedly secure the body, bladder and neck toeach other. More specifically, the method of manufacture includesextruding a first parison of the first polymer, co-extruding a secondparison of the second polymer within the first parison, sequentiallyco-extruding a third parison of the third polymer, and bonding the thirdpolymer (or neck) to each of the first and second polymers (or body andbladder).

As described above, the pump and one-way dispensing valve assembly 48 isco-molded and fixedly secured to the neck 18 to thereby form thevariable-volume chamber 16 that is hermetically sealed with respect toambient atmosphere. Upon assembly, the one-way dispensing valve 28 is influid communication with the variable-volume chamber 16, and thevariable-volume chamber 16 is hermetically sealed with respect toambient atmosphere.

The device defining the sealed, empty, variable-volume chamber is thensterilized such as by applying gamma radiation thereto. Alternatively,as described above, the pump and valve assembly may be assembled to theneck promptly upon molding when both parts are sterile or substantiallysterile due to the heat of molding. The sterile parts are preferablyautomatically assembled promptly upon molding, such as at the time ofdischarge from the molds or shortly thereafter, such as with a robot orother automated assembly device, under an overpressure of sterile air orother gas to form the device with an empty, sterile, variable-volumechamber.

The sealed, empty device defining the sterile variable-volume chamberthen may be aseptically filled. In the illustrated embodiment, theaseptic filling includes penetrating the penetrable and thermallyresealable portion 58 with an injection member (not shown) placed influid communication with the variable-volume chamber 16, filling thevariable-volume chamber through the injection member, withdrawing theinjection member, and thermally resealing, such as by applying laserenergy to, a resulting penetration aperture formed in the penetrable andthermally resealable portion.

In an alternative embodiment of the invention, rather than include apenetrable and thermally resealable portion, the pump and valve assembly48 includes a valve-in and vent-out assembly including a one-way fillingvalve for filling the variable-volume chamber 16 therethrough, and aone-way venting valve for venting gas from the variable volume chamberupon filling the fluid or substance into the variable-volume chamber 16.Preferably, the valve-in and vent-out assembly is co-molded with thepump and valve assembly 48 in the same manner, or substantially the samemanner that the penetrable and thermally resealable portion 58 isco-molded with the pump and valve the assembly.

In the alternative embodiments including the valve-in and vent-outassembly, the aseptic filling step includes placing a filling member influid communication with an inlet of the one-way filling valve; fillingthe sterile fluid through the filling member and one-way filling valveand into the variable-volume chamber; removing the filling member fromthe one-way filling valve; and sealing the variable-volume chamber withrespect to ambient atmosphere with the one-way filling valve.

The one-way valve and pump may take the form of any of numerousdifferent valves and/or pumps that are currently known, or that laterbecome known, including any of the one-way valves and/or pumps that aredisclosed in the following patents and patent applications that arehereby expressly incorporated by reference in their entireties as partof the present disclosure: U.S. patent application Ser. No. 11/650,102filed Jan. 5, 2007, entitled “One-Way Valve and Apparatus and Method ofUsing the Valve,” which is a continuation of claims priority to U.S.Provisional Application No. 60/757,161, filed Jan. 5, 2006, U.S. patentapplication Ser. No. 11/868,820 filed Oct. 8, 2007, entitled “One-WayValve and Apparatus Using the Valve,” which claims priority to U.S.Provisional Application No. 60/644,130 filed Jan. 14, 2005 and U.S.Provisional Application No. 60/633,322 filed Dec. 4, 2004, U.S.application Ser. No. 11/295,274 filed Dec. 5, 2005, entitled “One-WayValve and Apparatus Using the Valve,” now U.S. Pat. No. 7,278,553, whichclaims priority to U.S. Provisional Application No. 60/644,130 filedJan. 14, 2005 and U.S. Provisional Application No. 60/633,332 filed Dec.4, 2004, U.S. application Ser. No. 11/949,104 filed Dec. 3, 2007,entitled “Apparatus for Dispensing Fluids,” which is a division ofsimilarly-titled U.S. application Ser. No. 11/900,335 filed Sep. 10,2007, U.S. application Ser. No. 11/900,332 filed Sep. 10, 2007, entitled“Method for Dispensing Fluids,” which claims priority to U.S.Provisional Application No. 60/843,131 filed Sep. 8, 2006, U.S.application Ser. No. 11/900,227 filed Sep. 10, 2007, entitled “Apparatusfor Sealing and Engaging Sterile Chambers,” which claims priority toU.S. Provisional Application No. 60/843,131 filed Sep. 8, 2006, U.S.application Ser. No. 11/351,716 filed Feb. 10, 2006, entitled “FluidDispenser Having a one Way Valve, Pump, Variable Volume Storage Chamber,and a Needle Penetrable and Laser Resealable Portion,” U.S. applicationSer. No. 10/976,349 filed Oct. 28, 2004, entitled “Container and ValveAssembly for Storing and Dispensing Substances, and Related Method,” andU.S. application Ser. No. 11/935,194, filed Nov. 5, 2007, entitled“Dispenser and Method for Storing and Dispensing Sterile Food Product,”now U.S. Pat. No. 7,290,573.

Similarly, the penetrable and thermally resealable portion may take theform of any of numerous different penetrable and thermally resealableportions, that may be formed or otherwise provided on any portion of thedevice, and that may be filled with any of numerous different apparatusor methods that are currently known, or that later become known,including any apparatus and methods disclosed in the following patentsand patent applications that are hereby expressly incorporated byreference in their entireties as part of the present disclosure: U.S.Patent Application Ser. No. 60/981,107, entitled “Container Having aClosure and Removable Resealable Stopper for Sealing a SubstanceTherein,” filed on Oct. 18, 2007; U.S. Patent Application Ser. No.60/997,675 filed Oct. 4, 2007, entitled “Apparatus and Method forFormulating and Aseptically Filling Liquid Products;” U.S. patentapplication Ser. No. 12/245,678, filed Oct. 3, 2008, entitled “ApparatusFor Formulating And Aseptically Filling Liquid Products;” U.S. patentapplication Ser. No. 12/245,681, filed Oct. 3, 2008, entitled “MethodFor Formulating And Aseptically Filling Liquid Products;” U.S. patentapplication Ser. No. 11/408,704 filed Apr. 21, 2006, now U.S. Pat. No.7,243,689; U.S. patent application Ser. No. 10/766,172 filed Jan. 28,2004, entitled “Medicament Vial Having A Heat-Sealable Cap, AndApparatus and Method For Filling The Vial;” which is acontinuation-in-part of similarly titled U.S. patent application Ser.No. 10/694,364, filed Oct. 27, 2003, which is a continuation ofsimilarly titled co-pending U.S. patent application Ser. No. 10/393,966,filed Mar. 21, 2003, which is a divisional of similarly titled U.S.patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S.Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims thebenefit of similarly titled U.S. Provisional Application Ser. No.60/182,139, filed Feb. 11, 2000; similarly titled U.S. ProvisionalPatent Application No. 60/443,526, filed Jan. 28, 2003; similarly titledU.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003;U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003,entitled “Sealed Containers And Methods Of Making And Filling Same;”U.S. patent application Ser. No. 10/983,178 filed Nov. 5, 2004, entitled“Adjustable Needle Filling and Laser Sealing Apparatus and Method;” U.S.patent application Ser. No. 11/901,467 filed Sep. 17, 2007 entitled“Apparatus and Method for Needle Filling and Laser Resealing,” which isa continuation of similarly titled U.S. patent application Ser. No.11/510,961 filed Aug. 28, 2006, which is a continuation of similarlytitled U.S. patent application Ser. No. 11/070,440 filed Mar. 2, 2005;U.S. patent application Ser. No. 11/074,513 filed Mar. 7, 2005, entitled“Apparatus for Molding and Assembling Containers with Stoppers andFilling Same;” U.S. patent application Ser. No. 11/074,454 filed Mar. 7,2005, entitled “Method for Molding and Assembling Containers withStoppers and Filling Same;” U.S. patent application Ser. No. 11/339,966,filed Jan. 25, 2006, entitled “Container Closure With Overlying NeedlePenetrable And Thermally Resealable Portion And Underlying PortionCompatible With Fat Containing Liquid Product, And Related Method;” andU.S. patent application Ser. No. 11/786,206, filed Apr. 10, 2007entitled “Ready To Drink Container With Nipple And Needle Penetrable AndLaser Resealable Portion, And Related Method;” U.S. patent applicationSer. No. 11/295,251, filed Dec. 5, 2005, entitled “One-Way Valve,Apparatus and Method of Using the Valve;” U.S. patent application Ser.No. 11/933,272 filed Oct. 31, 2007, entitled “Sealed Containers andMethod of Making and Filling Same,” which is a continuation ofsimilarly-titled U.S. patent application Ser. No. 11/515,162 filed Sep.1, 2006; U.S. patent application Ser. No. 11/527,775 filed Sep. 25, 2006entitled “Sterile Filling Machine Having Needle Filling Station withinE-Beam Chamber,” which is a continuation of similarly-titled U.S. patentapplication Ser. No. 11/103,803 filed Apr. 11, 2005, which is acontinuation of similarly-titled U.S. patent application Ser. No.10/600,525; U.S. patent application Ser. No. 11/933,300 filed Oct. 31,2007 entitled “Device with Needle Penetrable and Laser ResealablePortion and Related Method,” and U.S. patent application Ser. No.11/949,087 filed Dec. 3, 2007, entitled “Device with Needle Penetrableand Laser Resealable Portion and Related Method.”

The valve-in and vent-out assembly may take the form of any of numerousdifferent valve-in and valve-out devices that are currently known, orthat later become known, that may be formed or otherwise provided on anyportion of the device, and that may be filled with any of numerousdifferent apparatus or methods that are currently known, or that laterbecome known, including any of the valve-in and valve-out devices, andany of numerous different apparatus and methods for filling suchdevices, disclosed in the patents and patent applications incorporatedby reference above and in following patents and patent applications thatare hereby expressly incorporated by reference in their entireties aspart of the present disclosure: U.S. patent application Ser. No.12/025,362 filed Feb. 4, 2008, entitled “Dispenser and Apparatus andMethod for Filling a Dispenser,” which is a continuation of similarlytitled U.S. patent application Ser. No. 11/349,873 filed Feb. 8, 2006,which is a continuation of similarly titled U.S. patent application Ser.No. 10/843,902 filed May 12, 2004; and U.S. patent application Ser. No.11/938,103 filed Nov. 9, 2007, entitled “Container and Valve Assemblyfor Storing and Dispensing Substances, and Related Method.”

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous changes and modifications may bemade to the above-described and other embodiments of the presentinvention without departing from its scope as defined in the appendedclaims. For example, any of numerous different materials, including anyof numerous different polymers, may be employed that are currentlyknown, or that later become known. Similarly, the device may take theform of any of numerous different devices, including any of numerousdifferent containers, or containers or other devices with or withoutvalves, penetrable and thermally resealable portions, and/or pumps, thatare currently known, or that later become known. Further, the devicesand methods of the present invention may be used to store and dispenseany of numerous different products or substances, including withoutlimitation, food products, such as low acid food products, dairy,milk-based, soy-based, water-based, juice-based or other food products,and pharmaceutical, ophthalmic, dermatological, and vaccine products,and industrial products, such as paints, adhesives, and components ofthe foregoing products. Although the device and method of the presentinvention are particularly suited for storing and dispensing sterileproducts that should be maintained sterile and hermetically sealed withrespect to ambient atmosphere during storage and throughout the periodof dispensing product from the device, they equally may be used withother products that are not sterile, or that do not require that theproduct be hermetically sealed with respect to ambient atmosphere.Accordingly, this detailed description of the currently preferredembodiments is to be taken in an illustrative as opposed to a limitingsense.

What is claimed is:
 1. A device comprising: a first portion including afirst polymer; a second portion that is relatively flexible incomparison to the first portion and fixedly secured therewith includinga second polymer that is substantially not bondable to the firstpolymer, and a chamber that is hermetically sealable with respect toambient atmosphere and defined by one or more of (i) an interior of thesecond portion, or (ii) a space formed between the first and secondportions; and a closure engaging the first portion and hermeticallysealing the chamber with respect to ambient atmosphere, the closureincluding a penetrable and resealable portion in fluid communicationwith the chamber and penetrable by one or more of an injection member, afilling member or a needle for introducing substance into the chamber,and a resulting penetration aperture in the penetrable and resealableportion is hermetically resealable to hermetically seal the chamber withrespect to ambient atmosphere.
 2. A device as defined in claim 1,wherein the first portion defines a relatively rigid outer body, and thesecond portion defines a relatively flexible inner bladder.
 3. A deviceas defined in claim 1, wherein the device further comprises a one-wayvalve in or placeable in fluid communication with the chamber, the oneway valve including valve seat and a valve member defining a partiallyannular seam therebetween, wherein the one-way valve further defines anormally closed position that hermetically seals the chamber withrespect to the ambient atmosphere, and an open position that allowssubstance to flow out of the chamber and device through the seam of theone-way valve.
 4. A device as defined in claim 1, wherein the secondportion is fixedly secured to the first portion by a third portionincluding a third polymer that is bondable to the first and secondpolymers.
 5. A device as defined in claim 1, wherein the penetrable andresealable portion is hermetically resealable by applying laserradiation or energy thereto.
 6. A device as defined in claim 1, whereinthe chamber is a variable volume chamber.
 7. A device as defined inclaim 1, wherein the first portion defines a neck portion and a baseportion, and the second portion is fixedly secured to the first portionsubstantially at the neck portion and substantially at the base portion.8. A device as defined in claim 1, wherein the chamber is defined by aninterior of the second portion, and the first portion is configured toallow ambient atmosphere to flow into a space defined between the firstand second portions.
 9. A method comprising the following steps: forminga first portion of a device including a first polymer; forming a secondportion of the device that is relatively flexible in comparison to thefirst portion and includes a second polymer that is substantially notbondable to the first polymer; fixedly securing the first portion to thesecond portion, and forming a chamber that is hermetically sealable withrespect to ambient atmosphere defined by one or more of (i) an interiorof the second portion, or (ii) a space formed between the first andsecond portions; and engaging a closure with the first portion, and inturn, hermetically sealing the chamber with respect to ambientatmosphere, the closure including a penetrable and resealable portionpenetrable by one or more of an injection member, a filling member or aneedle for introducing substance into the chamber, and a resultingpenetration aperture in the penetrable and resealable portion ishermetically resealable to hermetically seal the chamber with respect toambient atmosphere; wherein, with the closure engaging the firstportion, the penetrable and resealable portion is in fluid communicationwith the chamber.
 10. A method as defined in claim 9, furthercomprising: (a) penetrating the penetrable and resealable portion withan injection member, a filling member or a needle and, in turn, placingsaid injection member, filling member or needle in fluid communicationwith the chamber; (b) introducing substance into the chamber throughsaid injection member, filling member or needle; (c) removing saidinjection member, filling member or needle from the penetrable andresealable portion; and (d) hermetically resealing a resultingpenetration aperture in the penetrable and resealable portion and, inturn, hermetically sealing the chamber with respect to ambientatmosphere.
 11. A method as defined in claim 10, wherein step (d)includes resealing the penetrable and resealable portion by applyinglaser radiation or energy thereto.
 12. A method as defined in claim 9,wherein said engaging step includes forming a one-way valve in orplaceable in fluid communication with the chamber, the one way valveincluding valve seat and a valve member defining a partially annularseam therebetween, wherein the one-way valve further defines a normallyclosed position that hermetically seals the chamber with respect to theambient atmosphere, and an open position that allows substance to flowout of the device through the seam of the one-way valve.
 13. A method asdefined in claim 9, wherein the step of forming a first portion includesforming the first portion with a neck portion and a base portion, andthe securing step includes fixedly securing the second portion to thefirst portion substantially at the neck portion and substantially at thebase portion.
 14. A method as defined in claim 9, wherein the step offorming a chamber includes forming a chamber defined by an interior ofthe second portion, and the method further comprises allowing ambientatmosphere to flow into a space defined between the first and secondportions.
 15. A device comprising: a first portion defining a relativelyrigid outer body; a second portion defining a relatively flexible innerbladder fixedly secured to the first portion and a chamber defined byone or more of (i) an interior of the second portion, or (ii) a spaceformed between the first and second portions; and a closure engaging thefirst portion and hermetically sealing the chamber with respect toambient atmosphere, the closure including a penetrable and resealableportion in fluid communication with the chamber and penetrable by one ormore of an injection member, a filling member or a needle forintroducing substance into the chamber, and a resulting penetrationaperture in the penetrable and resealable portion is hermeticallyresealable to hermetically seal the chamber with respect to ambientatmosphere.
 16. A device as defined in claim 15, wherein the penetrableand resealable portion is hermetically resealable by applying laserradiation or energy thereto.
 17. A device as defined in claim 15,wherein the chamber is a variable volume chamber.
 18. A device asdefined in claim 15, wherein the first portion defines a neck portionand a base portion, and the second portion is fixedly secured to thefirst portion substantially at the neck portion and substantially at thebase portion.
 19. A device as defined in claim 15, wherein the chamberis defined by an interior of the second portion, and the first portionis configured to allow ambient atmosphere to flow into a space definedbetween the first and second portions.
 20. A method comprising:aseptically filling a device including a first portion defining arelatively rigid outer body, a second portion defining a relativelyflexible inner bladder fixedly secured to the first portion and achamber defined by one or more of (i) an interior of the second portion,or (ii) a space formed between the first and second portions, and aclosure engaging the first portion and hermetically sealing the chamberwith respect to ambient atmosphere, the closure including a penetrableand resealable portion in fluid communication with the chamber andpenetrable by one or more of an injection member, a filling member or aneedle for introducing substance into the chamber, and a resultingpenetration aperture in the penetrable and resealable portion ishermetically resealable to hermetically seal the chamber with respect toambient atmosphere, the filling step including (a) penetrating thepenetrable and resealable portion with an injection member, a fillingmember or a needle and, in turn, placing said injection member, fillingmember or needle in fluid communication with the chamber; (b)introducing substance into the chamber through said injection member,filling member or needle; (c) removing said injection member, fillingmember or needle from the penetrable and resealable portion; and (d)hermetically resealing a resulting penetration aperture in thepenetrable and resealable portion and, in turn, hermetically sealing thechamber with respect to ambient atmosphere.
 21. A method as defined inclaim 20, wherein step (d) includes resealing the penetrable andresealable portion by applying laser radiation or energy thereto.
 22. Amethod as defined in claim 20, wherein the chamber is defined by aninterior of the second portion, and the method further comprisesallowing ambient atmosphere to flow into a space defined between thefirst and second portions.
 23. A method as defined in claim 20, whereinthe device further includes a one-way valve in or placeable in fluidcommunication with the chamber, the one way valve including valve seatand a valve member defining a partially annular seam therebetween,wherein the one-way valve further defines a normally closed positionthat hermetically seals the chamber with respect to the ambientatmosphere, and an open position that allows substance to flow out ofthe chamber and device through the seam of the one-way valve, and themethod further includes dispensing substance in the chamber through thevalve and out of the device.
 24. A method as defined in claim 20,wherein the device further includes a pump, and the dispensing stepincludes pumping substance in the chamber above a valve opening pressureof the valve and, in turn, through the valve and out of the device. 25.A device comprising: a first portion defining a relatively rigid outerbody; a second portion defining a relatively flexible inner bladder anda chamber defined by one or more of (i) an interior of the secondportion, or (ii) a space formed between the first and second portionshermetically sealed from ambient atmosphere; and a one-way valve in orplaceable in fluid communication with the chamber, the one way valveincluding valve seat and a valve member defining a partially annularseam therebetween, wherein the one-way valve further defines a normallyclosed position that hermetically seals the chamber with respect to theambient atmosphere, and an open position that allows substance to flowout of the device through the seam of the valve.
 26. A device as definedin claim 25, further comprising a pump configured to pump substance inthe chamber through the valve and out of the device.
 27. A device asdefined in claim 25, wherein the valve member defines an interferencefit with the valve seat and a normally closed valve openingtherebetween, and wherein the valve member is movable from the closed tothe open position in response to substance at an inlet to the valveexceeding a valve opening pressure.
 28. A device as defined in claim 25,wherein the valve prevents the ingress of bacteria and othercontaminants into the device in both the closed and open positions.